The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Huntleigh Fp5000 System Model Fp5000.
| Device ID | K965153 |
| 510k Number | K965153 |
| Device Name: | HUNTLEIGH FP5000 SYSTEM MODEL FP5000 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Contact | Audrey Witko |
| Correspondent | Audrey Witko HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1998-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15055982700785 | K965153 | 000 |
| 15055982700754 | K965153 | 000 |